Preventive Sodium Lactate and Traumatic Brain Injury

Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury

The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.

Study Overview

• Status: Completed
• Conditions: Head Trauma
• Intervention / Treatment: Drug: half molar sodium lactate; Drug: isotonic sodium chloride

Detailed Description

• Intracranial hypertension is the most severe complication of severe head injury. This may lead to cerebral death or severe neurological outcome. To improve the prognosis of these patients,intracranial pressure must be maintained in normal range while maintaining cerebral perfusion pressure. Among numerous strategies, osmotherapy is frequently proposed to decrease intracranial pressure, using mannitol or hypertonic saline. Recently, it has been found that hypertonic sodium lactate infusion is more efficient to decrease intracranial hypertension compared with an equivalent volemic and osmotic mannitol administration.Thus, we hypothesized that a preventive sodium lactate infusion in severe head trauma could decrease the number of intracranial hypertensive episodes.
• Methods and Objectives : to compare in a randomized double-blind fashion two group of patients, i.e., those receiving a standard isotonic saline infusion (control group) with those receiving half-molar sodium lactate for 48 hours following admission in ICU. The primary endpoint is the number of any treatment required to control intracranial hypertensive episodes occurring during the first 48 hours following admission in ICU. Secondary endpoints are the effect of sodium lactate infusion on : intracranial pressure evolution;neurological outcome at 6 months (glasgow outcome scale); cerebral blood flow evaluated by transcranial doppler; and daily water balance
• Protocol consisted to measure as soon as possible baseline intracranial pressure and cerebral perfusion pressure, then immediately to begin the administration of 0.5 ml/kg/h intravenous isotonic saline perfusion or half-molar sodium lactate during 48 hours in a randomized double-blind fashion. Management of patients is the same for all patients. Treatment required for intracranial hypertensive episode is decided by a senior physician in charge of the patient. Sample size has been calculated considering that 50% of these patients will develop at least one intracranial hypertensive episode, each of them requiring at least 2 treatments. Based on previous results, we hypothesized that sodium lactate will decrease the number of required treatment by 2, leading to a sample size of 30 patients per group
• Follow up : 48 hours for treatments of intracranial hypertensive episodes; 6 months for the neurological outcome (glasgow outcome scale)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Institut d'Anesthesiologie des Alpes Maritimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• severe head trauma with a glasgow coma scale less than 9

Exclusion Criteria:

• prehospital cardiac arrest
• severe hemorrhage shock
• severe circulatory or respiratory failure
• medullar trauma
• prehospital osmotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: half sodium lactate; infusion of 0.5 ml/kg/day during 48 hours	Drug: half molar sodium lactate; intravenous infusion of 0.5 ml/kg during 48 hours; Other Names: sodium lactate
ACTIVE_COMPARATOR: isotonic sodium chloride; infusion of 0.5 ml/kg during 48 hours	Drug: isotonic sodium chloride; intravenous infusion of 0.5 ml/kg during 48 hours; Other Names: sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
the neurological outcome at six months evaluated by the glasgow outcome scale	6 months

Collaborators and Investigators

• Sponsor: Institut d'Anesthesiologie des Alpes Maritimes
• Collaborators: Université de Nice Sophia Antipolis; Medical University of Grenoble
• Investigators: Principal Investigator: Carole Ichai, MD, PhD, Institut d'Anesthesiologie des Alpes Maritimes

Publications and helpful links

General Publications

• Ichai C, Armando G, Orban JC, Berthier F, Rami L, Samat-Long C, Grimaud D, Leverve X. Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. Intensive Care Med. 2009 Mar;35(3):471-9. doi: 10.1007/s00134-008-1283-5. Epub 2008 Sep 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: October 10, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (ESTIMATE): October 15, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 9, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: intracranial hypertension; neurological outcome; osmotherapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Brain Injuries; Intracranial Hypertension; Craniocerebral Trauma
• Other Study ID Numbers: PA-Lac-TBI